Cleared Special

PERFADEX WITH THAM (K081997) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K081997 · Vitrolife Sweden AB · Gastroenterology & Urology device
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Oct 2008
Decision
87d
Days
Class 2
Risk

K081997 is an FDA 510(k) clearance for the PERFADEX WITH THAM. Classified as System And Accessories, Isolated Heart, Transport And Preservation (product code MSB), Class II - Special Controls.

Submitted by Vitrolife Sweden AB (Kungsbacka, SE). The FDA issued a Cleared decision on October 9, 2008 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5880 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Vitrolife Sweden AB devices

Submission Details

510(k) Number K081997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2008
Decision Date October 09, 2008
Days to Decision 87 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 130d · This submission: 87d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MSB System And Accessories, Isolated Heart, Transport And Preservation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5880
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - MSB System And Accessories, Isolated Heart, Transport And Preservation

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